Evaluating pain and activity levels after orthodontic separators
Pain Intensity Following the Placement of Orthodontic Separators in Healthy Volunteers and How it Correlates to Different Levels of Physical Activity?
This study is testing whether being more physically active helps people aged 18-49 feel less pain after getting orthodontic separators placed in their mouths.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT05615688 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the pain intensity experienced by healthy volunteers aged 18-49 following the placement of orthodontic separators. It hypothesizes that individuals with higher physical activity levels will report less pain compared to their less active counterparts. Participants will record their daily step counts and pain levels at 24-hour intervals over a week after separator placement. The study seeks to understand the relationship between physical activity and pain perception in orthodontic treatment.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 18-49 who are students, residents, or staff at the University of Kentucky with specific dental criteria.
Not a fit: Patients with chronic pain conditions or those currently using pain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help improve pain management strategies for patients undergoing orthodontic treatment.
How similar studies have performed: While there have been studies on pain perception in orthodontics, this specific approach linking physical activity levels to pain intensity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Student, resident, or staff at the University of Kentucky * Aged 18-49 at time of enrollment in the study * Erupted permanent first and second molars with interproximal contacts * Presence of antagonist teeth in the opposite arch with no open bite * Voluntary participation in study * Access to a smartphone, tablet, or computer * Valid email address Exclusion Criteria: * Any chronic pain condition (examples include trigeminal neuralgia, migraines, fibromyalgia, arthritis, neuropathies) * Current use of pain medication (analgesics, opioids, nerve pain medications) for any condition * Clinically evident interproximal decay in the site where separators will be placed * Missing teeth, variations in tooth anatomy, existing space, and or restorations that would keep separators from being placed or retained * If you do not have access to a computer, smartphone, or tablet with internet access
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Lina Sharab, DDS, MS, MSc — Assistant Professor, Orthodontics
- Study coordinator: Lina Sharab, DDS, MS, MSc
- Email: lsh232@uky.edu
- Phone: 859-323-7638
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.